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OMSULA 0.4 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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Package leaflet: Information for the user
Omsula 0.4 mg prolonged-release capsules, hard
Tamsulosin hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Omsula is and what it is used for
2.
What you need to know before you take Omsula
3.
How to take Omsula
4.
Possible side effects
5.
How to store Omsula
6.
Contents of the pack and other information
1.

What Omsula is and what it is used for

The active ingredient in Omsula is tamsulosin. This is a selective alpha1A/1D-adrenoceptor
antagonist. It reduces tension of the smooth muscles in the prostate and the urethra, enabling urine to
pass more readily through the urethra and facilitating urination.
Omsula is used to treat the symptoms of an enlarged prostate - a condition technically known as
benign prostatic hyperplasia or BPH. If the gland becomes enlarged, it can squeeze the urethra,
interfering with the flow of urine. This can cause difficulty in starting urination, a weak flow of urine,
and the need to urinate urgently or more frequently. Omsula doesn't shrink the prostate. Instead, it
relaxes the muscle around it, freeing the flow of urine and decreasing urinary symptoms.
2.

What you need to know before you take Omsula

Do not take Omsula
If you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine
(listed in section 6).
If you feel dizzy when you stand up.
If you have severe liver insufficiency.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omsula.
Before starting treatment you should tell your doctor if you are suffering from any other disease,
particularly from kidney and liver disorders, heart and circulatory system diseases.
Rarely, fainting can occur during the use of Omsula, as with other medicinal products of this
type. At the first signs of dizziness or weakness you should sit or lie down until they have
disappeared.
Periodic medical examinations are necessary to monitor the development of the condition you
are being treated for.

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If you are undergoing eye surgery because of cloudiness of the lens (cataract) or increased
pressure in the eye (glaucoma), please inform your eye specialist that you are using or have
previously used Omsula. This is because Omsula may cause complications during the surgery.
The specialist can then take appropriate precautions with respect to medication and surgical
techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop
taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or
increased pressure in the eye (glaucoma).

Children and adolescents
Do not give this medicine to children or adolescent under 18 years because it does not work in this
population.
Other medicines and Omsula
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
This is because Omsula can affect the way that some other medicines work and some other medicines
can affect the way that Omsula works.
In particular tell your doctor or pharmacist if you are taking:

Medicines to lower your blood pressure such as verapamil or diltiazem

Medicines to treat a fungal infection such as ketoconazole or itraconazole

Other alpha blockers such as doxazosin, indoramin, prazosin or alfuzosin

Erythromycin, an antibiotic used to treat infections
Please inform your doctor or dentist that you are on Omsula before any operation or dental procedure
as there is a potential that your medicine may interfere with the effects of the anaesthetic.
You should only take medicines concomitantly with Omsula if your doctor allows it.
Pregnancy, breast-feeding and fertility
Omsula is not indicated for use in women.
In men, abnormal ejaculation has been reported (ejaculation disorder). This means that the semen does
not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the
ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.
Driving and using machines
No data is available whether Omsula adversely affects the ability to drive or operate machines.
However it should be taken into account that in some patients drowsiness, blurred vision, dizziness
and transient loss of conciousness (syncope) may occur.
3.

How to take Omsula

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
If it is not prescribed otherwise by your doctor the recommended dose is one capsule daily, to be taken
after breakfast or the first meal of the day.
Do not crunch or chew the capsule, swallow it whole.
If you take more Omsula than you should
Contact your doctor immediately or visit the emergency department of the nearest hospital as the
consequences of accidental or deliberate overdose may require medical intervention.
If you forget to take Omsula

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Take the forgotten capsule on the same day. However, on the next day do not take a double dose to
make up for a forgotten dose; just resume treatment at one capsule a day.
If you stop taking Omsula
You should not stop taking it without consulting your doctor before.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not be
alarmed by this list of possible side effects, you may not have any of them. Most patients do not notice
any side effects. However if you do and they bother you, talk to your doctor.
If you begin to feel light-headed or dizzy, sit or lie down until you feel better.
Common (may affect up to 1 in 10 people):

abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via
the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume
is reduced or absent (ejaculation failure). This phenomenon is harmless.

dizziness, especially when you are getting up from a chair or bed
Uncommon (may affect up to 1 in 100 people):

dropping of blood pressure especially when standing up

feeling of rapid heartbeat

headache

constipation

diarrhoea

nausea

vomiting

hives

rash

itching

weakness

obstructed or runny nose
Rare (may affect up to 1 in 1000 people):

swelling of the lower layers of the skin, often around the mouth or of the mucosa of the mouth
or throat which can appear very quickly

fainting
Very rare (may affect up to 1 in 10 000 people):

a severe inflammatory eruption of the skin and mucous membranes, which is an allergic
reaction to drugs or other substances called Stevens-Johnson syndrome

priapism (painful, persistent, involuntary erection of the penis), in which case immediate
medical aid is needed
Not known (frequency cannot be estimated from the available data):

nose bleeding

dry mouth

blurred vision, visual impairment

serious skin rashes (erythema multiforme, dermatitis exfoliative)
As with other medicines of this type, drowsiness, blurred vision or swelling of the hands and feet can
occur.

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If you are undergoing eye surgery because of cloudiness of the lens (cataract) or increased pressure in
the eye (glaucoma) and are already taking or have previously taken tamsulosin hydrochloride, the
pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during
the procedure (see also section 2 “Warnings and precautions”).
In addition to the adverse events listed above, very rapid uncoordinated contractions of the heart,
abnormal heart rhythm, abnormally rapid heartbeat and shortness of breath have been reported in
association with Omsula use. Because these spontaneously reported events are from the worldwide
post-marketing experience, the frequency of events and the role of Omsula in their causation cannot be
reliably determined.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.
5.

How to store Omsula

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Omsula contains
The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin
hydrochloride.
The other ingredients are:
capsule filling:
microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per
cent (including polysorbate, sodium laurylsulfate), talc, triethyl citrate, calcium stearate.
capsule shell:
yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172), titanium dioxide
(E171), gelatin.
What Omsula looks like and contents of the pack
White or off-white pellets are filled in the capsules which sizes are about 18 mm lengthwise and
6.3 mm in external diameter, the upper part is brown opaque, lower part is buff opaque.
30, 90 or 100 capsules are packed into clear or white opaque PVC/PVDC//Aluminium blisters.
The blisters are packed into folding box with a package leaflet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.

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1103 Budapest
Hungary
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany: Omsula
United Kingdom: Omsula
This leaflet was last revised in December 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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